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作 者:谢晶鑫[1] 程显隆[1] 乔婧 魏锋[1] 赵宗阁[1] 孙会敏[1] Xie Jingxin;Cheng Xianlong;Qiao Jing;Wei Feng;Zhao Zongge;Sun Huimin(National Institutes for Food and Drug Control,Beijing 102629,China)
出 处:《中国药事》2024年第12期1371-1378,共8页Chinese Pharmaceutical Affairs
摘 要:目的:提升对照药材的生产供应效率,保障市场和监管需求。方法:梳理医保目录和基本药物目录所涉及标准中的对照药材使用情况,分析对照药材在《中华人民共和国药典》中的使用频次与供应量的趋势关系,并选取具有代表性的影响因素进行风险评估。结果:优化的预警策略可快速聚焦应急品种,进一步完善对照药材的供应工作,保证品种批间无缝衔接。结论:通过识别影响对照药材预警控制的风险因素,分析在国家标准中对照药材的使用情况和市场需求数据,可达到优化预警工作的目的,为有效提升对照药材的生产供应效率提供参考。Objective:To improve the production and supply efficiency of reference drug and ensure the market and regulatory needs.Methods:The usage of reference drug in the document standards involving the National Reimbursement Drug List and the National Essential Medicines List was sorted out.The trend relationship between the frequency of use and supply of reference drug in the Chinese Pharmacopoeia was analyzed,and representative influencing factors for risk assessment were selected.Results:The optimizing early-warning strategies can quickly focus on in-short-supply reference drug,improve the supply of reference drug,and ensure the accurate seamless connection between batches.Conclusion:Through the identification of risk factors influencing the early-warning,and the analysis of the data of the use in the national standards and market demand of reference drug,the aim of optimizing the early-warning work is achieved,which provides a reference for effectively enhancing the production and supply efficiency of herbal reference drug.
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